NCT06777498Recruiting
The Precision Nutrition New York Study
Optimizing Dietary Fiber Eating Patterns to Prevent Obesity and Resulting Metabolic Disorders
Source: ClinicalTrials.gov · Last updated 11 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Dietary fiber has been shown to have beneficial effects on human health through its impact on microbes present in the gut. However, these effects can vary between individuals, and everyone may not reap the same health benefits by eating the same sources of fiber. Factors predicting how an individual's gut microbes as well as the beneficial metabolites produced by these microbes change in response to different sources of fiber would be helpful in developing precision nutrition approaches that maximize the benefits of dietary fiber. The objective of this study is to evaluate candidate predictors of gut microbiota response to fiber sources from either whole grains or fruits and vegetables.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 6 Jan 2025
- Start date
- 13 Jan 2025
- Primary completion date
- 1 Oct 2025
- Lead sponsor
- Cornell University
- Diseases
- Obesity
- NCT number
- NCT06777498
What you commit to
- Study type: Interventional
- Planned participants: 15
- From 13 Jan 2025 to the primary completion date, 1 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Electronic medical implant, for example, a pacemaker.
- A chronic, clinically significant (unresolved, requiring ongoing medical management or medication) pulmonary, cardiovascular, gastrointestinal, hepatic, or renal functional abnormality.
- Previously had bariatric surgery.
- An unstable dietary history as defined by major changes in diet during the previous month. For example, elimination or significantly increased intake of a major food group in the diet.
Other illness
- An existing, UNTREATED, thyroid condition.
- An acute disease at the time of enrollment (Acute disease is defined as the presence of a moderate or severe illness with or without fever).
- Any suspected state of immunosuppression or immunodeficiency including HIV.
- A history of active UNTREATED gastrointestinal disorders or diseases including
- Inflammatory bowel disease (IBD)
- Ulcerative colitis (mild-moderate-severe)
- Crohn's or celiac disease
- Indeterminate colitis
- Irritable bowel syndrome (IBS) (moderate-severe)
- Persistent, infectious gastroenteritis, colitis or gastritis
- Persistent or chronic diarrhea of unknown etiology
- Clostridium difficile infection (recurrent)
- Chronic constipation
- Recent history of chronic alcohol consumption defined as more than 5 drinks (or servings) of alcohol per day.
Other
- Use of systemic antibiotics (intravenous injection, intramuscular, or oral) within the last 4 months.
- Female participants: pregnant/lactating.
Who the study is looking for
- Age is between 21-50 years
- BMI is between 25-30. You can check your BMI here: https://www.cdc.gov/bmi/adult-calculator/index.html
- Must be able to have height, weight, waist, and hip circumference, and body composition measured during the study
- Must be able to provide saliva samples.
- Must be able to provide a phone number and email address at which the study investigators can contact for study-related matters.
- Must be able to increase dietary fiber intake to the recommended level following the instructions on the USDA MyPlate website: https://www.myplate.gov/myplate-plan
- Must be able to provide food records of everything consumed (food, beverage, and supplements) on one weekday and one weekend day (example Tuesday, Saturday) every week during the study. This will be done using an online survey.
- Must be able to provide 10 stool samples over 11 weeks of the study duration. 18) Must have stable weight (within ±3% of usual body weight) for the last two months.
- Must be able to to take an online survey to assess recent dietary fiber intake to determine eligibility.
Age in the registry: 21 years to 50 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cornell University Coordinator of this site? Confirm its status | Ithaca | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.